Clinical Trial: The Clinical Study of Atorvastatin and Dexamethasone on Treatment for Chronic Subdural Hematoma in the Patients With Coagulation Disorders

Study Status: Active, not recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: The Clinical Study of Atorvastatin and Dexamethasone on Treatment for Chronic Subdural Hematoma in the Patients With Coagulation Disorders

Brief Summary: To evaluate Efficacy and Safety of oral Atorvastatin and Dexamethasone on conservative treatment for Chronic Subdural Hematoma (CSDH) patients with Coagulation Disorders

Detailed Summary:

Study design: Two-arm,Evaluator-blinded study

Subjects: CSDH patients with Coagulation Disorders（Conservative treatment is adopted）

Sample size: 60 cases, 30 in Atorvastatin and Dexamethasone-treated group, 30 in Atorvastatin-treated group.


Sponsor: Oriental Neurosurgery Evidence-Based-Study Team

Current Primary Outcome: Changes of hematoma volume [ Time Frame: 2,5,12 weeks during treatment ]

After 5 weeks' treatment, the hematoma will be assessed, then the therapy will be continued according to follow-up processes.Head CT to all the patients will be performed before the treatment, after the 2nd week and 5th week during treatment (at the end), at the 12th week during the follow-up.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Outcome score (GOSE) in subjects [ Time Frame: 2,5,12 weeks during treatment ]
  • Changes of peripheral blood for later tested SDF-1a, Treg, CXCR4 and related analysis [ Time Frame: 2,5,12 weeks during treatment ]
  • Changes of neurological symptoms and signs [ Time Frame: 2,5,12 weeks during treatment ]
  • Recurrence and prognosis of patient failure in those conservative treatment [ Time Frame: 2,5,12 weeks during treatment ]
  • Outcome score (ADL-BI Scale) in subjects [ Time Frame: 2,5,12 weeks during treatment ]


Original Secondary Outcome: Same as current

Information By: Oriental Neurosurgery Evidence-Based-Study Team

Dates:
Date Received: July 11, 2014
Date Started: July 2014
Date Completion: September 2015
Last Updated: March 25, 2015
Last Verified: March 2015